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1 New oral anticoagulants and antiplatelets: Where do they fit? Meredith Hollinger, PharmD BCPS Clinical Pharmacy Specialist, Cardiology September 2012

2 Objectives Describe the mechanisms of action for novel oral anticoagulants Discuss the advantages and disadvantages with the novel oral anticoagulants and antiplatelets Identify therapeutic options for reversal of oral anticoagulants

9 Administration Do not break, chew, or open capsules Manipulation of product can cause a 75% increase in absorption and potentially serious adverse reactions Administer with water Can be taken without regard to meals Dosage Forms 75mg and 150mg capsules

17 Administration Dose 15mg/day should be administered with food 10mg/day may be administered without regard to meals Do not administer via a feeding tube that delivers rivaroxaban directly into the small intestine or colon (ie J-tube) due to a decrease in the max concentration

20 Monitoring and Reversal Monitoring In Phase I and II studies Factor Xa activity did not completely return to baseline within 24 hours for doses >5mg Affects both the PT and aptt in a dose dependent manner, although PT may be more sensitive Reversal Antidote? None available Supportive Care Activated charcoal Ideally within 2 hours of ingestion Consider FFP, RBC s, recombinant factor VIIa and PCC s can also be considered

21 Surgical Considerations Recommended timing for discontinuation of rivaroxaban prior to surgery or invasive procedure High Risk of Bleeding* Standard Risk of Bleeding 24 to 48 hours (may be longer based on renal function) Minimum of 24 hours * Examples of high risk bleeding include: cardiac surgery, neurosurgery, abdominal surgery, and surgeries involving a major organ. Spinal anesthesia may require complete hemostasis and is therefore considered high risk. Other determinants of bleeding risk include advanced age, comorbidities and concomitant use of antiplatelet therapy. ** Neuraxial anesthesia: Avoid removal of epidural catheter for at least 18 hours following last rivaroxaban dose; avoid rivaroxaban administration for at least 6 hours following epidural catheter removal; if traumatic puncture occurs, avoid rivaroxaban for at least 24 hours.

23 Controversies Dabigatran Discovered after study closure, data re-analyzed Increased rate of silent MI Meta-analysis confirmed results that patients are at an increased risk of MI or ACS Dabigatran grp 1.9% and control grp 0.79% Rivaroxaban Rebound Effect Related to lack of guidance at end of study for prescribers Patients in rivaroxaban group were not transitioned from rivaroxaban to warfarin appropriately, putting them at risk for stroke

28 Clopidogrel Concerns Drug Interactions PPIs Manufacturer recommendation Avoidance of PPIs or use of a PPI with less potent CYP2C19 inhibition (ie pantoprazole) ACCF/ACG/AHA Patients with multiple risk factors for GI bleeding continue to use a PPI, regardless of degree of CYP2C19 inhibition

29 Clopidogrel Resistance? More appropriate term: Non-responder Reported to vary between 4% and 44% among different populations VerifyNow P2Y12 Point of care assay Utilized to detect platelet reactivity Used for both aspirin and clopidogrel reactivity Test 5-7 days after starting clopidogrel 75mg daily OR 2-6 hours after a LD of clopidogrel May be helpful in selection of medications for nonresponders Mayo Clinic: Clopidogrel Platelet Function Tests. 2012

34 Black Box Warnings Warnings and Precautions Not recommended for patients 75 yrs of age Not recommended for initiation in patients likely to undergo CABG Additional Risk factors for bleeding Body weight < 60kg Propensity to bleed Concomitant use of medications that increase the risk of bleed

37 Black Box Warnings Can cause significant, sometimes fatal, bleeding Contraindications Active pathological bleeding History of intracranial hemorrhage Aspirin dose and effectiveness A loading dose of 325mg of aspirin can be given Maintenance doses of aspirin should not exceed 100mg

40 Antiplatelets Role in Practice 2011 PCI guideline recommendations After PCI, use of aspirin should be continued indefinitely (LOE: A) After PCI, it is reasonable to use aspirin 81mf per day in preference to higher maintenance doses (LOE: B) Levine et al ACCF/AHA/SCAI PCI Guideline. JACC 2011: 58 (24); e

Essentia Health Med Moment Short Video Tune-Up A brief overview of a new medication, or important new medication information Rivaroxaban (Xarelto ) by Richard Mullvain RPH BCPS (AQC) Current - August 2011

Disclosures The New Oral Anticoagulants: Are they better than Warfarin? Alan P. Agins, Ph.D. does not have any actual or potential conflicts of interest in relation to this CE activity. Alan Agins, Ph.D.

Prescriber Guide 20mg Simply Protecting More Patients 15mg Simply Protecting More Patients 1 Dear Doctor, This prescriber guide was produced by Bayer Israel in cooperation with the Ministry of Health as

New Oral Anticoagulants in the Management of Atrial Fibrillation June, 2012 By Deborah K Brokaw, Pharm.D. Introduction Since the 1950 s, the only orally available anticoagulant has been the vitamin K antagonist

TABLE OF CONTENTS New Oral Anticoagulant (Rivaroxaban [Xarelto]) 1-2 New Antiplatelet (Ticagrelor [Brilinta]) 2-3 Update on Dabigatran (Pradaxa) Safety and Use at UIMCC 3-4 What Methods are Available for

The New Anticoagulants are Here! Do you know how to use them? Arrhythmia Winter School February 11 th, 2012 Jeff Healey RELY: A New Era in AF Connolly SJ et al. N Engl J Med 2009;361:1139-1151 ROCKET-AF:

Anticoagulation: How Do I Pick From All the Choices? Jeffrey H. Neuhauser, DO, FACC BHHI Primary Care Symposium February 28, 2014 Atrial Fibrillation 2 Atrial Fibrillation The most common arrhythmia encountered

SEPTEMBER 2012 CCPN SPAF Tool STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF): POCKET REFERENCE Approximately 20% of all strokes are attributable to Atrial Fibrillation (AF). 1 Of these, 20% will result

Dabigatran (Pradaxa) Guidelines Dabigatran is a new anticoagulant for reducing the risk of stroke in patients with atrial fibrillation. Dabigatran is a direct thrombin inhibitor, similar to warfarin, without

Guideline for the Prescribing of Novel Oral Anticoagulants (NOACs): Dabigatran (Pradaxa ), Rivaroxaban (Xarelto ), Apixaban (Eliquis ) The contents of this CPG are to be used as a guide. Healthcare professionals

Antiplatelet and Antithrombotics From clinical trials to guidelines Ashraf Reda, MD, FESC Prof and head of Cardiology Dep. Menofiya University Preisedent of EGYBAC Chairman of WGLVR One of the big stories

The 2 nd World Congress on CONTROVERSIES IN HEMATOLOGY (COHEM) Barcelona, Spain September 6 8, 2012 New anticoagulants: Monitoring or not Monitoring? Not Monitoring Anna Falanga, MD Immunohematology and

Critical Bleeding Reversal Protocol Coagulopathy, either drug related or multifactorial, is a major contributing factor to bleeding related mortality in a variety of clinical settings. Standard therapy

TEGH Family Practice Clinic Day April 4, 03 Use of Anticoagulants in 03: What s New (and What Isn t) Bill Geerts, MD, FRCPC Director, Thromboembolism Program, Sunnybrook HSC Professor of Medicine, University

New Developments in Oral Anticoagulants: Treating and Preventing Embolic Events in the 21 st Century David Stewart, PharmD, BCPS Associate Professor of Pharmacy Practice East Tennessee State University

MEDICAL ASSISTANCE HBOOK I. Requirements for Prior Authorization of Anticoagulants A. Prescriptions That Require Prior Authorization Prescriptions for Anticoagulants which meet any of the following conditions

COMPARISON OF NEW ORAL ANTICOAGULANTS AND FREQUENTLY- ASKED QUESTIONS FROM PATIENTS AND PHYSICIANS TARGET AUDIENCE: All Canadian health care professionals. OBJECTIVES: To provide a comparison of the new

Comparative Anticoagulation Laurajo Ryan, PharmD, MSc, BCPS, CDE Clinical Associate Professor The University of Texas at Austin College of Pharmacy The University of Texas Health Science Center Pharmacotherapy

What You Should NOAC About the New Anticoagulants Dr Calum Young Cardiologist Overview The Burden of AF What s Wrong With Warfarin? The Era of NOACs NOACs in New Zealand Clinical Trials with NOACs Potential

New Oral Anticoagulants How safe are they outside the trials? Objectives The need for anticoagulant therapy Indications for anticoagulation Traditional anticoagulant therapies Properties of new oral anticoagulants

Dabigatran (Pradaxa) 1 Dabigatran (Pradaxa) for stroke prevention in patients with non-valvular atrial fibrillation (da-big-a-tran) Similar rate of major bleeding to warfarin KEY POINTS Dabigatran is an

SEPTEMBER 2013 CCPN SPAF Tool STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF): POCKET REFERENCE Approximately 20% of all strokes are attributable to Atrial Fibrillation (AF). 1 Of these, 20% will result

The New Kids on the Block: Oral Anticoagulants Lauren E. Odum, PharmD, BCPS Clinical Assistant Professor UMKC School of Pharmacy at MU April 11, 2014 Objectives Be able to Understand the major trials leading